Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Third Edition is a comprehensive and up-to-date guide for professionals and academics engaged in all aspects of oral dosage form development, from discovery support through commercial manufacturing. This new edition features 13 new or rewritten chapters, along with significant updates to existing content, reflecting the latest advancements in the field, including new theories, scientific findings, approaches, techniques, modeling, and the emerging opportunities offered by AI.
This book consists of 44 chapters covering in-depth principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their applications throughout the R&D process and commercial production of oral dosage forms. New chapters address topics such as absorption evaluation of oral dosage forms, formulation principles, and applications based on supersaturation, patient-centric product design, product design through the 505(b)(2) NDA pathway, design of experiments (DoE), process modeling, 3D printing, and machine learning applications in commercial manufacturing. Existing chapters have been updated or completely rewritten to provide advanced information and include practical case studies. Important topics such as amorphous solid dispersions, modified-release delivery, manufacturing technologies, modeling and simulation, fundamentals of dissolution and bioequivalence, IVIVC, biowaivers, regulatory frameworks, and many others are covered.
The new edition of this book is an indispensable resource for industry professionals, academic institutions, and regulatory bodies seeking to stay current with advances in solid dosage form development and manufacturing. It offers a thorough understanding of fundamental principles and techniques, along with practical guidance on applying these concepts to real-world challenges.
1. Title of Book - p. i 2. Cover image - p. i 3. Title page - p. ii 4. Table of Contents - p. iii 5. Copyright - p. iv 6. Dedication - p. v 7. List of contributors - p. xxvii 8. Foreword - p. xxix 9. Copyright - p. xxx 10. List of contributors - p. xxv 11. Foreword - p. xxvi 12. Volume 1 - p. V1 13. Part 1: Theoretical principles and characterization of drug substances and excipients - p. P2 14. Chapter 1. Solubility of pharmaceutical solids - p. 3 15. Chapter 2. Crystalline and amorphous solids - p. 27 16. Chapter 3. Solid state characterization and techniques - p. 65 17. Chapter 4. Active pharmaceutical ingredient solid form screening and selection - p. 93 18. Chapter 5. Drug stability and stability studies - p. 129 19. Chapter 6. Excipient compatibility and functionality - p. 175 20. Chapter 7. Polymer properties and characterization - p. 203 21. Chapter 8. Interfacial phenomena - p. 255 22. Chapter 9. Fundamental of diffusion and dissolution - p. 285 23. Chapter 10. Particle, powder, and compact characterization - p. 305 24. Part II: Fundamental principles of biopharmaceutics and evaluation of oral absorption - p. P328 25. Chapter 11. Oral absorption basics: pathways, physicochemical and biological factors affecting drug absorption - p. 329 26. Chapter 12. Evaluation of drug absorption from oral dosage forms - p. 369 27. Chapter 13. Dissolution testing of solid products - p. 411 28. Chapter 14. Bioavailability and bioequivalence of orally delivered drug products - p. 451 29. Chapter 15. In vitro–in vivo correlations: fundamentals, development considerations and applications - p. 473 30. Chapter 16. Oral delivery of challenging poorly soluble drugs via supersaturation: Principles and applications - p. 519 31. Index - p. 551 32. Volume 2 - p. V2 33. Part III: Design, development, and scale-up of drug products and manufacturing processes - p. P572 34. Chapter 17. Patient-centric drug product design: rationale and practical considerations - p. 573 35. Chapter 18. Design of improved and differentiated products through 505(b)(2) new drug application pathway - p. 585 36. Chapter 19. Oral formulations for preclinical studies: principle, design, and development considerations - p. 611 37. Chapter 20. Product and process development of solid oral dosage forms - p. 655 38. Chapter 21. Rational design of amorphous solid dispersions - p. 693 39. Chapter 22. Rational design of oral modified-release drug delivery systems - p. 733 40. Chapter 23. Basic principles of the design of experiments - p. 777 41. Chapter 24. Established unit operation models for solid oral dosage forms from an industrial perspective - p. 807 42. Chapter 25. Analytical method development of solid dosage forms - p. 841 43. Chapter 26. Statistical design and analysis of long-term stability studies for drug products - p. 861 44. Chapter 27. Packaging selection for solid oral dosage forms - p. 885 45. Chapter 28. Clinical supplies manufacture: strategy, good manufacturing practice considerations, and cleaning validation - p. 907 46. Chapter 29. Specification setting and manufacturing process control for solid oral drug products - p. 933 47. Chapter 30. Process development, optimization, and scale-up providing reliable powder flow and product uniformity - p. 953 48. Chapter 31. Capsules dosage form: formulation and manufacturing considerations - p. 989 49. Chapter 32. Design, development, and scale-up of the high-shear wet granulation process - p. 1021 50. Chapter 33. Process development, optimization, and scale-up: fluid-bed granulation - p. 1057 51. Chapter 34. Process development and scale-up: spray dried amorphous solid dispersions for insoluble drugs - p. 1075 52. Chapter 35. Process development and scale-up: twin screw extrusion - p. 1111 53. Chapter 36. Development, scale-up, and optimization of process parameters: roller compaction theory and practice - p. 1163 54. Chapter 37. Tablet compression - p. 1219 55. Chapter 38. Development, optimization, and scale-up of process parameters: pan coating - p. 1275 56. Chapter 39. Development, optimization, and scale-up of process parameters: Wurster coating - p. 1333 57. Chapter 40. Ensuring commercial manufacturing and product quality through science- and artificial intelligence-driven approaches - p. 1357 58. Chapter 41. Continuous manufacturing: modernizing pharmaceutical manufacturing with advanced technologies and 3D printing - p. 1385 59. Part IV: Regulatory aspects of product development - p. P1414 60. Chapter 42. Drug product approval in the United States - p. 1415 61. Chapter 43. Modern pharmaceutical regulations: quality assessment for drug substances - p. 1439 62. Chapter 44. Modern pharmaceutical regulations: quality assessment for drug products - p. 1463 63. Index - p. 1497
Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Third Edition is a comprehensive and up-to-date guide for professionals and academics engaged in all aspects of oral dosage form development, from discovery support through commercial manufacturing. This new edition features 13 new or rewritten chapters, along with significant updates to existing content, reflecting the latest advancements in the field, including new theories, scientific findings, approaches, techniques, modeling, and the emerging opportunities offered by AI.
This book consists of 44 chapters covering in-depth principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their applications throughout the R&D process and commercial production of oral dosage forms. New chapters address topics such as absorption evaluation of oral dosage forms, formulation principles, and applications based on supersaturation, patient-centric product design, product design through the 505(b)(2) NDA pathway, design of experiments (DoE), process modeling, 3D printing, and machine learning applications in commercial manufacturing. Existing chapters have been updated or completely rewritten to provide advanced information and include practical case studies. Important topics such as amorphous solid dispersions, modified-release delivery, manufacturing technologies, modeling and simulation, fundamentals of dissolution and bioequivalence, IVIVC, biowaivers, regulatory frameworks, and many others are covered.
The new edition of this book is an indispensable resource for industry professionals, academic institutions, and regulatory bodies seeking to stay current with advances in solid dosage form development and manufacturing. It offers a thorough understanding of fundamental principles and techniques, along with practical guidance on applying these concepts to real-world challenges.
1. Title of Book - p. i 2. Cover image - p. i 3. Title page - p. ii 4. Table of Contents - p. iii 5. Copyright - p. iv 6. Dedication - p. v 7. List of contributors - p. xxvii 8. Foreword - p. xxix 9. Copyright - p. xxx 10. List of contributors - p. xxv 11. Foreword - p. xxvi 12. Volume 1 - p. V1 13. Part 1: Theoretical principles and characterization of drug substances and excipients - p. P2 14. Chapter 1. Solubility of pharmaceutical solids - p. 3 15. Chapter 2. Crystalline and amorphous solids - p. 27 16. Chapter 3. Solid state characterization and techniques - p. 65 17. Chapter 4. Active pharmaceutical ingredient solid form screening and selection - p. 93 18. Chapter 5. Drug stability and stability studies - p. 129 19. Chapter 6. Excipient compatibility and functionality - p. 175 20. Chapter 7. Polymer properties and characterization - p. 203 21. Chapter 8. Interfacial phenomena - p. 255 22. Chapter 9. Fundamental of diffusion and dissolution - p. 285 23. Chapter 10. Particle, powder, and compact characterization - p. 305 24. Part II: Fundamental principles of biopharmaceutics and evaluation of oral absorption - p. P328 25. Chapter 11. Oral absorption basics: pathways, physicochemical and biological factors affecting drug absorption - p. 329 26. Chapter 12. Evaluation of drug absorption from oral dosage forms - p. 369 27. Chapter 13. Dissolution testing of solid products - p. 411 28. Chapter 14. Bioavailability and bioequivalence of orally delivered drug products - p. 451 29. Chapter 15. In vitro–in vivo correlations: fundamentals, development considerations and applications - p. 473 30. Chapter 16. Oral delivery of challenging poorly soluble drugs via supersaturation: Principles and applications - p. 519 31. Index - p. 551 32. Volume 2 - p. V2 33. Part III: Design, development, and scale-up of drug products and manufacturing processes - p. P572 34. Chapter 17. Patient-centric drug product design: rationale and practical considerations - p. 573 35. Chapter 18. Design of improved and differentiated products through 505(b)(2) new drug application pathway - p. 585 36. Chapter 19. Oral formulations for preclinical studies: principle, design, and development considerations - p. 611 37. Chapter 20. Product and process development of solid oral dosage forms - p. 655 38. Chapter 21. Rational design of amorphous solid dispersions - p. 693 39. Chapter 22. Rational design of oral modified-release drug delivery systems - p. 733 40. Chapter 23. Basic principles of the design of experiments - p. 777 41. Chapter 24. Established unit operation models for solid oral dosage forms from an industrial perspective - p. 807 42. Chapter 25. Analytical method development of solid dosage forms - p. 841 43. Chapter 26. Statistical design and analysis of long-term stability studies for drug products - p. 861 44. Chapter 27. Packaging selection for solid oral dosage forms - p. 885 45. Chapter 28. Clinical supplies manufacture: strategy, good manufacturing practice considerations, and cleaning validation - p. 907 46. Chapter 29. Specification setting and manufacturing process control for solid oral drug products - p. 933 47. Chapter 30. Process development, optimization, and scale-up providing reliable powder flow and product uniformity - p. 953 48. Chapter 31. Capsules dosage form: formulation and manufacturing considerations - p. 989 49. Chapter 32. Design, development, and scale-up of the high-shear wet granulation process - p. 1021 50. Chapter 33. Process development, optimization, and scale-up: fluid-bed granulation - p. 1057 51. Chapter 34. Process development and scale-up: spray dried amorphous solid dispersions for insoluble drugs - p. 1075 52. Chapter 35. Process development and scale-up: twin screw extrusion - p. 1111 53. Chapter 36. Development, scale-up, and optimization of process parameters: roller compaction theory and practice - p. 1163 54. Chapter 37. Tablet compression - p. 1219 55. Chapter 38. Development, optimization, and scale-up of process parameters: pan coating - p. 1275 56. Chapter 39. Development, optimization, and scale-up of process parameters: Wurster coating - p. 1333 57. Chapter 40. Ensuring commercial manufacturing and product quality through science- and artificial intelligence-driven approaches - p. 1357 58. Chapter 41. Continuous manufacturing: modernizing pharmaceutical manufacturing with advanced technologies and 3D printing - p. 1385 59. Part IV: Regulatory aspects of product development - p. P1414 60. Chapter 42. Drug product approval in the United States - p. 1415 61. Chapter 43. Modern pharmaceutical regulations: quality assessment for drug substances - p. 1439 62. Chapter 44. Modern pharmaceutical regulations: quality assessment for drug products - p. 1463 63. Index - p. 1497
